Global Regulatory Affairs Specialist

Position OverviewInternational Regulatory Specialist (EU MDR) - Medical DeviceRole Summary:The International Regulatory Specialist is tasked with ensuring adherence to EU regulatory standards and oversees the comprehensive international regulatory submission process.Essential Qualifications:Required - Minimum Qualifications:Education: Bachelor's...

Job OverviewInternational Regulatory Specialist (EU MDR) - Medical DevicePosition SummaryThe International Regulatory Specialist is tasked with ensuring adherence to EU regulatory standards and is responsible for overseeing the international regulatory submission framework.Essential Qualifications:Required - Minimum Qualifications:Education: Bachelor's...

About CorDxCorDx is a global biotechnology firm dedicated to advancing innovation and supply in the realm of global health. With a workforce exceeding 2,100 professionals worldwide, we serve millions of users across more than 100 countries. Our focus is on delivering rapid testing and point-of-care medical device solutions for the detection of infectious...

About Eko Devices: Eko is committed to enhancing the capabilities of healthcare professionals by providing cutting-edge digital solutions for cardiopulmonary assessment. Our innovative platform empowers clinicians to accurately identify and manage cardiopulmonary conditions, ensuring optimal patient care.Company Growth: With substantial backing exceeding...

Join Our TeamInvivoscribe is a premier organization committed to Precision Diagnostics aimed at improving lives. With over 25 years of expertise, we have been leaders in the global standardization of testing and providing access to innovative cancer therapies.Located in the dynamic region of San Diego, California, our international reach enables us to...

Regulatory Affairs Specialist Opportunity at CorDxCorDx, a prominent biotechnology firm committed to advancing global health, is seeking a Regulatory Affairs Specialist to enhance our proactive Regulatory Affairs division. In this pivotal role, you will be instrumental in ensuring adherence to FDA standards for our In Vitro Diagnostics (IVD) offerings.Key...

Job TitleLead Regulatory Affairs Specialist-Coronary VascularJob SummaryAs a Lead Regulatory Affairs Specialist, you will have a key role in ensuring the safety, effectiveness, and compliance of Philips Image-Guided Therapy Devices (IGTD) Coronary Vascular (CV) products with global regulatory standards. Role Highlights:Provide guidance to internal teams...

About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Pharmatech Associates. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring the compliance of our clients' projects with global regulatory requirements.Key ResponsibilitiesCMC and Clinical Regulatory Expertise: You will...

Position Title: Regulatory Affairs SpecialistCompany: Katalyst HealthCares & Life SciencesEmployment Type: ContractDuration: 12 monthsDepartment: Regulatory AffairsQualifications: Bachelor’s or Master’s degree in a relevant Scientific Discipline At least 7 years of experience in the pharmaceutical sector Minimum of 5 years of experience in CMC regulatory...

Regulatory Compliance Specialist Opportunity at CorDxCorDx, a prominent biotechnology firm committed to advancing global health, is seeking a Regulatory Compliance Specialist to enhance our proactive Regulatory Affairs division. In this pivotal role, you will be instrumental in ensuring adherence to FDA standards for our In Vitro Diagnostics (IVD)...

About Danaher Corporation: Danaher Corporation is a global leader in the life sciences and diagnostics sectors, committed to innovation and excellence in our products and services.Position Overview: We are seeking a Senior Specialist in Regulatory Affairs for Core and NGS Technologies. This role is integral to our Quality Assurance and Regulatory Affairs...

Exciting Opportunity in Regulatory AffairsAre you an experienced professional with a strong background in global regulatory management and project execution? As a pivotal member of Cypress HCM, you will be instrumental in advancing our objectives within the pharmaceutical sector. In the role of Regulatory Affairs Director, you will be responsible for...

About Radionetics OncologyRadionetics Oncology is a clinical-stage biotechnology company dedicated to the discovery and development of innovative radiopharmaceuticals for the treatment of various oncology indications. With a strong focus on novel radiotherapeutics, the company is poised to capitalize on the growing demand for effective cancer...

Job OverviewAbout CorDx:CorDx is a global biotechnology firm dedicated to advancing innovation and supply in the realm of global health. With a workforce exceeding 2,100 professionals worldwide, we cater to millions of users across more than 100 countries. Our focus is on delivering rapid testing and point-of-care medical device solutions for the detection...

Strategic Role in Regulatory AffairsAre you an experienced professional with a strong interest in international regulatory management and project oversight? As a key player in the pharmaceutical sector, you will assume a vital position in steering the development of innovative products while ensuring adherence to local and global regulations.Key...

Opportunity for a Regulatory Affairs Manager at CorDxCorDx, a prominent biotechnology firm focused on advancing global health solutions, is seeking a Regulatory Affairs Manager to enhance our proactive Regulatory Affairs team. In this pivotal role, you will be instrumental in ensuring adherence to FDA regulations for our In Vitro Diagnostics (IVD)...

Director of Global Regulatory AffairsDepartment: RegulatoryLocation: San DiegoJoin a global team dedicated to transforming the lives of individuals affected by rare diseases.At Travere Therapeutics, we understand that our outstanding workforce is crucial to our achievements. We are a committed group focused on addressing the specific needs of patients with...

R&D Partners is looking for a Senior Regulatory Affairs Specialist III. Key Responsibilities: Support for marketed products, including reviewing engineering modifications, labeling, promotional content, product alterations, and documentation to ensure compliance with both US and international regulatory standards.Draft and maintain submissions and product...

Job SummaryWe are seeking a highly experienced and skilled Executive Director, Regulatory Affairs to join our team at Travere Therapeutics. This is a key leadership role that will be responsible for developing and executing global regulatory strategic and tactical guidance for the development of innovative new drugs in rare disease.Key...

Senior Regulatory Affairs SpecialistGenalyte, Inc., a frontrunner in cutting-edge diagnostic solutions, is seeking a highly qualified and driven Senior Regulatory Affairs Specialist to become part of their innovative team. In this position, you will be tasked with navigating intricate regulatory frameworks to guarantee adherence to all standards and...